Triple Negative Breast CancerPhase 2NCT07610525
Blood and imagE-guided Optimization of Neoadjuvant Therapy in People With Early Stage Triple-negative Breast cancER - the BETTER Trial
A Phase 2 study testing Paclitaxel + Carboplatin and Pembrolizumab in people with Triple Negative Breast Cancer and Blood and Image Guided, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn whether certain blood and imaging tests can show which people with early-stage TNBC may already have had a complete response to chemotherapy before they go to surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer, Blood and Image Guided, Optimization of Neoadjuvant Therapy
- What is being tested?
- Paclitaxel + Carboplatin and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2026to 15 Jan 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be 18 years of age or older, able to understand and give written informed consent.
- Histologically proven TNBC, defined as ER ≤10%, PR ≤10%, and HER2 negative based on the 2023 ASCO/CAP guidelines.
- Clinical stage T1cN1-2 or T2-4N0-2 TNBC according to the primary tumor-regional lymph node anatomic staging criteria of the American Joint Committee on Cancer (AJCC), 8th edition.
- Medically eligible to receive immunotherapy in combination with chemotherapy as part of standard of care
- Willingness to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female Participants, between the onset of menses (as early as 8 years of age) and 55 years unless the Participant presents with an applicable exclusionary factor which may be one of the following:
- Postmenopausal (no menses greater than or equal to 12 consecutive months).
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- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- No active viral hepatitis (hepatitis B or C) at baseline
Who cannot join
- Stage IV (metastatic) breast cancer
- History of any prior (ipsi- or contralateral) invasive breast cancer. Note: Prior DCIS is allowed.
- History of other malignancies within the last 5 years except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, stage I uterine cancer, or other non-breast malignancies with an outcome similar to those mentioned above.
- Prior excisional biopsy of the primary invasive breast cancer.
- Participants with cognitive impairment/psychiatric illness/social situations that would limit compliance with study requirements.
- Participants not medically eligible for chemotherapy with taxanes, carboplatin, and/or anthracycline-based chemotherapy regimens
- Participants not medically eligible for immunotherapy
- Pregnant women are excluded from this study because of the potentially detrimental effect of magnetic resonance imaging on the fetus.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
MD Anderson Cancer Center
Houston, Texas, 77030
Akshara S Raghavendra, MD, 713-792-2817, TNBC-NOW@mdanderson.org
Clinton Yam, MD
About this study
Official title: Blood and imagE-guided Optimization of Neoadjuvant Therapy in People With Early Stage Triple-negative Breast cancER - the BETTER Tria
To learn whether certain blood and imaging tests can show which people with early-stage TNBC may already have had a complete response to chemotherapy before they go to surgery.
Read the detailed description
Primary Objectives To determine the rate of pCR in participants with high-risk, early-stage TNBC who have no residual enhancement on MRI and undetectable ctDNA after receiving neoadjuvant pembrolizumab plus carboplatin plus paclitaxel and proceed with surgery without receiving doxorubicin and cyclophosphamide in the neoadjuvant setting
- Conditions
- Triple Negative Breast Cancer, Blood and Image Guided, Optimization of Neoadjuvant Therapy, Phase 2
- Being tested
- Paclitaxel + Carboplatin, Pembrolizumab
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel + CarboplatinDrug
Given by IV
PembrolizumabDrug
Given by IV
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1 | Experimental | Cohort A1 Omiting AC/PB: Paclitaxel+Carboplatin+Pembrolizumab x 4 cycles Receives: Drug: Paclitaxel + Carboplatin; Drug: Pembrolizumab |
| Cohort A2 | Experimental | Cohort A2 Receiving AC/PB: Paclitaxel+Carboplatin+Pembrolizumab x 4 cycles + (AC/PB) x 4 cycles Receives: Drug: Paclitaxel + Carboplatin; Drug: Pembrolizumab |
| Cohort B1 | Experimental | Cohort B1 Receiving AC/PB: Paclitaxel+Carboplatin+Pembrolizumab x 4 cycles + (AC/PB) x 4 cycles Receives: Drug: Paclitaxel + Carboplatin; Drug: Pembrolizumab |
| Cohort B2 | Experimental | Cohort B2 Omiting AC/PB: Paclitaxel+Carboplatin+Pembrolizumab x 4 cycles Receives: Drug: Paclitaxel + Carboplatin; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs).
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start5 Nov 2026 (estimated)
- Primary completion15 Jan 2029 (estimated)
- Study completion15 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clinton Yam, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610525
- Sponsor's protocol ID
- 2026-0293
- Other IDs
- NCI-2026-03701
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood and imagE-guided Optimization of Neoadjuvant Therapy in People With Early Stage Triple-negative Breast cancER - the BETTER Tria
- ClinicalTrials.gov ID
- NCT07610525
- Acronym / sponsor ID
- 2026-0293
- Conditions
- Triple Negative Breast Cancer, Blood and Image Guided, Optimization of Neoadjuvant Therapy, Phase 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 5 Nov 2026 (estimated)
- Primary completion
- 15 Jan 2029 (estimated)
- Study completion
- 15 Jan 2031 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To learn whether certain blood and imaging tests can show which people with early-stage TNBC may already have had a complete response to chemotherapy before they go to surgery.
Detailed description
Primary Objectives To determine the rate of pCR in participants with high-risk, early-stage TNBC who have no residual enhancement on MRI and undetectable ctDNA after receiving neoadjuvant pembrolizumab plus carboplatin plus paclitaxel and proceed with surgery without receiving doxorubicin and cyclophosphamide in the neoadjuvant setting
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A1 | Experimental | Drug: Paclitaxel + Carboplatin, Drug: PembrolizumabCohort A1 Omiting AC/PB: Paclitaxel+Carboplatin+Pembrolizumab x 4 cycles |
| Cohort A2 | Experimental | Drug: Paclitaxel + Carboplatin, Drug: PembrolizumabCohort A2 Receiving AC/PB: Paclitaxel+Carboplatin+Pembrolizumab x 4 cycles + (AC/PB) x 4 cycles |
| Cohort B1 | Experimental | Drug: Paclitaxel + Carboplatin, Drug: PembrolizumabCohort B1 Receiving AC/PB: Paclitaxel+Carboplatin+Pembrolizumab x 4 cycles + (AC/PB) x 4 cycles |
| Cohort B2 | Experimental | Drug: Paclitaxel + Carboplatin, Drug: PembrolizumabCohort B2 Omiting AC/PB: Paclitaxel+Carboplatin+Pembrolizumab x 4 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participants must be 18 years of age or older, able to understand and give written informed consent.
- Histologically proven TNBC, defined as ER ≤10%, PR ≤10%, and HER2 negative based on the 2023 ASCO/CAP guidelines.
- Clinical stage T1cN1-2 or T2-4N0-2 TNBC according to the primary tumor-regional lymph node anatomic staging criteria of the American Joint Committee on Cancer (AJCC), 8th edition.
- Medically eligible to receive immunotherapy in combination with chemotherapy as part of standard of care
- Willingness to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female Participants, between the onset of menses (as early as 8 years of age) and 55 years unless the Participant presents with an applicable exclusionary factor which may be one of the following:
Key exclusion criteria (8 listed)
- Stage IV (metastatic) breast cancer
- History of any prior (ipsi- or contralateral) invasive breast cancer. Note: Prior DCIS is allowed.
- History of other malignancies within the last 5 years except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, stage I uterine cancer, or other non-breast malignancies with an outcome similar to those mentioned above.
- Prior excisional biopsy of the primary invasive breast cancer.
- Participants with cognitive impairment/psychiatric illness/social situations that would limit compliance with study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel + CarboplatinGiven by IV | Drug | Cohort A1, Cohort A2, Cohort B1, Cohort B2 |
| PembrolizumabGiven by IV | Drug | Cohort A1, Cohort A2, Cohort B1, Cohort B2 |
Primary outcome
Safety and adverse events (AEs).
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinton Yam, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel + Carboplatin and Pembrolizumab in people with Triple Negative Breast Cancer and Blood and Image Guided, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akshara S Raghavendra, MD (713-792-2817, TNBC-NOW@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs). (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.